prepare-labelling-negotiation-brieflisted

Structures the clinical pharmacology input to a labelling negotiation — assembling the evidence for each CP labelling position, mapping each position to its regulatory precedent, and identifying where the evidence supports the position and where it does not. Use when preparing for a labelling review or negotiation meeting. Do not use for drafting label text, for taking a negotiating position, or for predicting what an agency will accept.
malekokour/clinpharm-pmx-skills · ★ 6 · AI & Automation · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# Labelling Negotiation Brief Preparation Labelling negotiation with the agency — produce a source-linked finding register a qualified reviewer can act on. Every finding carries a locator, a severity, and a detection path. The register arrives open; only a named human may close an item. > **Skills review, reconcile, verify, structure and flag. Qualified humans > decide, approve, sign off, submit and act.** ## Who this is for Clinical pharmacology or pharmacometrics practitioners working in **Product information** who need a bounded, repeatable review of this L3 task — not a decision, not a draft to submit, and not a substitute for the accountable human owner. ## When to use this skill - "Prepare the CP evidence brief for the labelling negotiation" - "What evidence supports our proposed Section 12 content?" - "Map our DDI labelling positions to regulatory precedent" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | Draft label text | Authoring | Labelling owner | | Decide the labelling position | A strategic decision | Programme leadership | | Predict agency acceptance | Speculation | Out of scope | ## Required inputs Ask for these by artifact, not by category. If one is missing, say which check it disables rather than proceeding silently. | # | Input | Form | Role | |---|---|---|---| | I1 | Draft labelling positions for CP content | Document/table | Positio